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TENDOSHOCK-2010 Combination Therapy for Athletic Tendinopathies

Sponsor
Hannover Medical School (Other)
Overall Status
Unknown status
CT.gov ID
NCT01185951
Collaborator
(none)
114
Enrollment
1
Location
3
Arms
47
Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Athletic tendinopathies of the upper and lower extremity are often therapeutically challenging. Colour and Power-Doppler-ultrasound visualizes pathological neovessels in painful tendons, which are associated with pain-mediating nerve fibres in such tendinopathies. These neovessels are represented by an increased capillary blood flow at the point of pain. Painful eccentric training reduces pain and improves function in Achilles tendinopathy substantially (evidence level Ib). Shock wave therapy in combination with eccentric training is superior to eccentric training alone (evidence level Ib). Long-term results suggest a collagen induction and reduced pain following topical glyceryl trinitrate (NO) (evidence level Ib). Colour- and Power-Doppler-guided sclerosing therapy using polidocanol reduces pain, improves function and may lead to tendon remodelling (evidence level Ib). Pain-restricted sport beyond pain level 5/10 during therapy is recommended (evidence level Ib). 3x10min of cryotherapy reduce pain and capillary blood flow (evidence level Ib). The role of proprioceptive training in tendinopathy has to be determined in future randomized-controlled trials (evidence level II).

The investigators thought to evaluate the combination of the aforementioned individually successfully therapeutic options in athletes to shorten the recovery period and return to play interval.

Condition or Disease Intervention/Treatment Phase
  • Drug: Polidocanol
  • Device: Focused extracorporeal shock wave therapy
  • Drug: Topical NO
  • Behavioral: Painful eccentric training in Achilles tendinopathy
  • Behavioral: Painful eccentric training for patella tendinopathy on 25° decline board
  • Behavioral: Painful eccentric training for elbow tendinopathy using Thera-Band Flex-Bar
 Phase 2

Detailed Description

Interventions:

Combined Power-Doppler-guided sclerosing therapy using Polidocanol (0.5%, 2ml) in 6-8 week intervals combined with extracorporeal focused shockwave therapy (STORZ Duolith 2000impulses 0.25mJ/mm2) every 6-8weeks plus painful daily eccentric training plus daily topical NO

Study Design

Study Type:
Interventional
Actual Enrollment :
114 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
TENDOSHOCK-2010 - Combined Sclerosing Therapy, Extracorporeal Shockwave Therapy, Eccentric Training and Topical Glyceryl Trinitrate for Athletic Tendinopathies
Study Start Date :
Jan 1, 2007
Anticipated Primary Completion Date :
Aug 1, 2010
Anticipated Study Completion Date :
Dec 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Achilles tendinopathy

Patients suffering both, insertional and midportion Achilles tendinopathy seeking medical help. All patients were evaluated with a standardized Power-Doppler ultrasound to detect the level of neovascularisation at the point of pain.

Drug: Polidocanol
Power-Doppler-guided extratendinous sclerosing therapy using Polidocanol 0.5% up to 2ml every 6-8 weeks

Device: Focused extracorporeal shock wave therapy
Focused extracorporeal shock wave therapy using a STORZ Duolith machine 2000 Impulses 0.25mJ/mm2 every 6-8 weeks

Drug: Topical NO
Topical nitroglycerine (Nitrolingualspray(R)) 2x2 hubs per day over 6 months daily on the painful tendon

Behavioral: Painful eccentric training in Achilles tendinopathy
Painful eccentric training for Achilles tendinopathy on a stair single-stance with 6x15 repetitions per leg and day over at least 12 weeks
Active Comparator: Patella tendinopathy

Patients suffering patella tendinopathy seeking medical help. All patients were evaluated with a standardized Power-Doppler ultrasound to detect the level of neovascularisation at the point of pain.

Drug: Polidocanol
Power-Doppler-guided extratendinous sclerosing therapy using Polidocanol 0.5% up to 2ml every 6-8 weeks

Device: Focused extracorporeal shock wave therapy
Focused extracorporeal shock wave therapy using a STORZ Duolith machine 2000 Impulses 0.25mJ/mm2 every 6-8 weeks

Drug: Topical NO
Topical nitroglycerine (Nitrolingualspray(R)) 2x2 hubs per day over 6 months daily on the painful tendon

Behavioral: Painful eccentric training for patella tendinopathy on 25° decline board
Painful eccentric training for patella tendinopathy on a 25° decline board single-stance with 6x15 repetitions per leg and day over at least 12 weeks
Active Comparator: Epikondylitis

Patients suffering both, lateral (tennis elbow) or medial (golfers' elbow) elbow tendinopathy seeking medical help. All patients were evaluated with a standardized Power-Doppler ultrasound to detect the level of neovascularisation at the point of pain.

Drug: Polidocanol
Power-Doppler-guided extratendinous sclerosing therapy using Polidocanol 0.5% up to 2ml every 6-8 weeks

Device: Focused extracorporeal shock wave therapy
Focused extracorporeal shock wave therapy using a STORZ Duolith machine 2000 Impulses 0.25mJ/mm2 every 6-8 weeks

Drug: Topical NO
Topical nitroglycerine (Nitrolingualspray(R)) 2x2 hubs per day over 6 months daily on the painful tendon

Behavioral: Painful eccentric training for elbow tendinopathy using Thera-Band Flex-Bar
Painful eccentric training for elbow tendinopathy using a green coloured Thera-Band Flex-Bar with painful supination and pronation with 6x15 repetitions per day over at least 12 weeks

Outcome Measures

Primary Outcome Measures

  1. Functional impairment of the Achilles tendon using VISA-A score [0=worse, 100=perfect] [up to 4 years]

    Score of patient-related outcome measure: Achilles tendon: VISA-A [0=worse, 100=perfect] derived from eight validated questions on pain and function during activities of daily living

  2. Functional impairment of the patella tendon according to the VISA-P score [0=worse, 100=perfect] [up to 4 years]

    Score of patient-related outcome measure: Patella tendon: VISA-P [0=worse, 100=perfect] derived from eight validated questions on pain and function during daily activities

  3. Functional impairment due to epicondylitis measured by the DASH score [0=perfect, 100=worse] [up to four years]

    Score of patient-related outcome measure: Epicondylitis: DASH score [0=perfect, 100=worse] derived from 30 validated questions regarding the impairment in activities of daily living

Secondary Outcome Measures

  1. Pain level at rest [VAS 0-10] [up to 4 years]

  2. Pain level at exertion [VAS 0-10] [up to 4 years]

  3. Patient satisfaction on Likert scale [1-6] [up to 4 years]

    Patient satisfaction on Likert scale from 1=perfect, wholy satisfied, to 6=worst, dissatisfied

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Painful tendons at the Achilles tendon (both insertional and mid-portion tendinopathy)

  • patella tendinopathy

  • elbow tendinopathy

  • informed consent

Exclusion Criteria:

  • no informed consent

  • no painful tendons

  • allergy against Polidocanol

  • current treatment with Marcumar

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hannover Medical School, Plastic, Hand and Reconstructive Surgery Hannover Germany 30625

Sponsors and Collaborators

  • Hannover Medical School

Investigators

  • Principal Investigator: Karsten Knobloch, MD, Hannover Medical School, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01185951
Other Study ID Numbers:
  • TENDOSHOCK-2010
First Posted:
Aug 20, 2010
Last Update Posted:
Aug 20, 2010
Last Verified:
Aug 1, 2010
Keywords provided by , ,
Achilles Tendon
Patella
Allergy
Necrosis
Infection
Additional relevant MeSH terms:
Tendinopathy
Polidocanol

Study Results

No Results Posted as of Aug 20, 2010